Akeso, Inc. · HKEX:9926
Akeso — H1 2021 Earnings Presentation
57 slides from Akeso's earnings presentation, August 2021
Slide 1: Akeso, Inc. 2021 Interim Results Presentation
rN Akesobio RA+WNR(BS)SRAA Akeso, Inc. 2021 Interim Results Presentation August 2021
Slide 2: Disclaimer
Disclaimer This presentation has been delivered to interested parties for information purposes only and upon the express understanding that such parties will use it only for the purposes set forth above, and it is not intended to form the basis of any investment decision or any decision to purchase
Slide 3: Agenda
Agenda 1 Overview of 1H2021 2 Product Updates 3 Future Milestones and Catalysts 4 Financial Highlights 3
Slide 4: Overview of 1H2021
™ SECTION 1 Overview of 1H2021
Slide 5: Akeso: a biopharmaceutical company committed to in-house discovery and development
Akeso: a biopharmaceutical company committed to in-house discovery, development & commercialization of first-in-class and best-in-class therapies 1 2 3 4 World-class GMP All In-House Developed Synergistic Compliant ACE 1 Innovative Products Collaborations Manufacturing Facilities - Fully Integrated
Slide 6: Major accomplishments in 1H2021
Major accomplishments in 1H2021 1 1 3 2 9 15 NDA BLA / NDA registrational trials trials advanced approval submitted trials reached advanced to to Phase Ib/II endpoints Pivotal/ Phase III AK105: cHL AK104: AK104: AK104: GC/GEJ Products/indications cervical AK104+AK109 AK120 Akeso's first cervical can
Slide 7: Solid and expedited development of our clinical programs
Solid and expedited development of our clinical programs AK104 (PD-1/CTLA-4) AK112 (PD-1/VEGF) Major progress achieved recently Emerging as a potentially very promising and better solution compared with approved anti-PD1 agents for 2L/3L cervical 1L gastric 1L cervical NSCLC 1L RCC cancer cancer can
Slide 8: Penpulimab (PD-1)
Solid and expedited development of our clinical programs (cont’d) Penpulimab (PD-1) Penpulimab received NDA approval in August 2021. We shipped first batch of Penpulimab on 21 August, and doctors prescribed first batch of Penpulimab on 23 August. 8
Slide 9: Major accomplishments in 2021
Major accomplishments in 2021 1 Business development 8 Regulator’s recognition FDA real-time oncology review: AK105, NPC milestone payment received Breakthrough therapy: AK105, NPC; AK104, cervical cancer FDA Orphan drug: AK105, NPC; AK104, cervical cancer FDA Fast track: AK105, NPC; AK104, cervical
Slide 10: Strategically expanding our footprint in China
Strategically expanding our footprint in China We continue to expand our team by strategically opening offices in Beijing, Shanghai, Guangzhou and Zhongshan, together with capacity expansion by building world class manufacturing facilities As of 30 June 2021, 1,202 employees in total R&D and clinica
Slide 11: Our core commercialization team with extensive experience
Our core commercialization team with extensive experience Target to build a team with 1,000+ members for the commercialization of Cadonilimab. We currently have 300+ experienced members on board. Head of Commercialization ➢ Over 25 years of extensive experience ➢ Excellent track record in building c
Slide 12: Product Updates
@ SECTION 2 Product Updates
Slide 13: Akeso clinical pipeline landscape
Akeso clinical pipeline landscape PD1/LAG3 PD1 / PD1 / Oncology PD1/CD73 TIGIT VEGF CTLA4 TIGIT/TGFbeta CD47 CD73 PD1 Degree of Innovation VEGFR2 Stage IND Enabling/ P1 P2 (Incl. P2B) P3 NDA Approved Submission IL12 / IL17 IL23 IL4R PCSK9 CD73 Immunology and Others 13 Legend: Current status Previous
Slide 14: Oncology products
t Akesobio Oncology products
Slide 15: Cadonilimab (AK104) PD-1/CTLA-4 bispecific
Cadonilimab (AK104) PD-1/CTLA-4 bispecific 15
Slide 16: Cadonilimab – clinical development plan
1 Cadonilimab (PD-1/CTLA-4) – clinical development plan Focusing on combo trials for large indications and mono trials for unmet medical needs for fast approval. Status Comm. Pivotal/ Drug Candidate Target Rights Mono / Combo Indication Phase Ia Phase Ib/II Phase III NDA Submitted Mono 2L/3L cervica
Slide 17: Cadonilimab – clinical efficacy data (2L/3L cervical cancer)
1 Cadonilimab – clinical efficacy data (2L/3L cervical cancer) Cadonilimab showed superior anti-tumor activity in cervical cancer in comparison to either PD-1 plus CTLA-4 combination therapy or PD-1 monotherapy ORR CR DCR 33.0% 20.0% 16.4% 12.0% 13.0% 5.0% 3.3% 2.0% Cadonilimab Balstilimab Balstilim
Slide 18: Cadonilimab – preliminary efficacy data (Phase II, 1L cervical cancer)
1 Cadonilimab – preliminary clinical efficacy data (Phase II, 1L cervical cancer) ➢ Phase II clinical trial of 2L/3L cervical cancer has obtained approval from the CDE for NDA submission ➢ It has been granted priority review, breakthrough therapy, fast-track and orphan drug designation Phase II stud
Slide 19: Cadonilimab – clinical efficacy data (Phase II, 1L GC/GEJ)
1 Cadonilimab – clinical efficacy data (Phase II, 1L GC/GEJ) Cadonilimab in combination with chemo showed superior efficacy and improved OS regardless of PD-L1 expression status in 1L GC/GEJ Checkmate-6493 Cadonilimab Cadonilimab Keynote-0621 Checkmate-6492 Cadonilimab Cadonilimab Chinese Subgroup +
Slide 20: Cadonilimab – clinical efficacy data (Phase II, 1L HCC)
1 Cadonilimab – clinical efficacy data (Phase II, 1L HCC) 1L Hepatocellular Carcinoma (HCC) Cadonilimab in combination with Lenvatinib showed promising efficacy in 1L HCC IMbrave 150 Keynote 524 AK104+Lenventinib (Atezo+Bev)1 (Pembro+Leventinib)2 (N=46) (N=336) (N=100) Median OS (months) NR 19.2 22.
Slide 21: Cadonilimab – preliminary efficacy data (Phase II, 1L PD-L1(+) NSCLC)
Cadonilimab – preliminary clinical efficacy data (Phase II, 1L PD- 1 L1(+) NSCLC) Cadonilimab+Anlotinib combo trial demonstrated superior preliminary results for 1L PD-L1(+) NSCLC AK104 15 mg/kg Q3W + Pembrolizumab+ Anlotinib in NSCLC Pembrolizumab in NSCLC2 Ramucirumab in NSCLC1 (TPS 1≥%) (TPS ≥1%)
Slide 22: Cadonilimab – preliminary efficacy data (Advanced RCC)
1 Cadonilimab – preliminary clinical efficacy data (Advanced RCC) CC CC CC ORR (ccRCC) = 40% (2/5); ORR (nccRCC) = 60% (3/5) Pembrolizumab: 28% for papillary nccRCC, and 9.5% for chromophobe nccRCC (Keynote 427) Cadonilimab demonstrated promising efficacy in RCC Partnership with Pfizer to start Cado
Slide 23: Cadonilimab – clinical safety data summary
Cadonilimab (PD-1/CTLA-4) – clinical safety data summary 1 (monotherapy & combo therapy) Checkmate-214 CheckMate-511 Cadonilimab melanoma renal cell carcinoma Categories overall (Nivo 3+Ipi 1) Nivo 3+Ipi 1 Nivo 1+Ipi 3 (N=458) (N=547) (N=180) (N=178) TRAE 82.8% 93% 85.6% 93.8% Grade 3-4 TRAE 18.8% 4
Slide 24: Cadonilimab (AK104) – comprehensive plan for commercialization
1 Cadonilimab (AK104) – comprehensive plan for commercialization Exciting clinical development and Huge addressable market for commercialization outlook commercialization with AK104 as a backbone ✓ Completed registrational trial for 2L/3L advanced cervical cancer with superior efficacy results GC/GE
Slide 25: AK112 PD-1/VEGF bispecific
AK112 PD-1/VEGF bispecific 25
Slide 26: AK112 (PD-1/VEGF) – clinical development plan
2 AK112 (PD-1/VEGF) – clinical development plan We are executing a global clinical development strategy for AK112. Status Drug Comm. Phase Pivotal/ NDA Candidate Target Rights Mono / Combo Indication Phase Ia Ib/II Phase III Submitted +Chemo 1L EGFRwt NSCLC Registrational +Chemo EGFR-TKI failure NSC
Slide 27: AK112 – clinical safety data summary
2 AK112 (PD-1/VEGF) – clinical safety data summary AK112 demonstrates good safety profile and is well-tolerated ▪ As of August 2021, 117 subjects were enrolled in 6 cohorts ranging from 0.3mg/kg to 30mg/kg ✓ 10mg/kg Q2W (n=28), 20mg/kg Q2W (n=32), 30 mg/kg Q2W (n=10), and 20 mg/kg Q3W (n=11) IMmotio
Slide 28: AK112 – clinical efficacy data (Phase Ia)
2 AK112 (PD-1/VEGF) – clinical efficacy data (Phase Ia) AK112 demonstrated Anti-tumor promising activity of AK112 in Phaseanti-tumor activity Ia trial (N=45, at doses ≥3mg/kg in patients with various 0.3-30mg/kg) tumor types that have been heavily pretreated (including with bevacizumab or ICI) and r
Slide 29: AK112 – preliminary efficacy data (PD-L1(+) NSCLC)
2 AK112 – preliminary clinical efficacy data (PD-L1(+) NSCLC) AK112 monotherapy demonstrated potentially superior anti-tumor activities in comparison to PD-1+VEGF combo therapies in PD-L1(+) NSCLC AK112 in PD-L1+ NSCLC Pembrolizuma+ Ramucirumab Pembrolizumab in PD-L1+ (N=10) in PD-L1+ 1L NSCLC (N=26
Slide 30: AK112 – efficacy data (AK112+chemo for 1L NSCLC)
2 AK112 – preliminary clinical efficacy data (AK112+chemo for 1L NSCLC) AK112 + chemo combo demonstrated promising anti-tumor activities in 1L NSCLC Both non-squamous & squamous NSCLC 10 mg/kg + 20 mg/kg ORR=59.3% (16/27) DCR=100% Data cutoff date: Aug 13, 2021 Note: 1. D. Rodríguez-Abreu et al.2021
Slide 31: AK112 – efficacy data (AK112+chemo for 1L NS-NSCLC)
2 AK112 – preliminary clinical efficacy data (AK112+chemo for 1L NS-NSCLC) AK112 + chemo combo demonstrated promising anti-tumor activities in 1L NS-NSCLC Non-squamous NSCLC AK112 20 mg/kg Q3W AK112 10 mg/kg AK112 (10 + 20) mg/kg Pembrolizumab+Chemo Response +Chemo Q3W +Chemo Q3W +Chemo (KEYNOTE-189
Slide 32: AK112 – efficacy data (1L PD-L1(-) and PD-L1(+) NSCLC)
AK112 – preliminary clinical efficacy data (AK112+chemo for 1L PD-L1(-) 2 NSCLC & PD-L1(+) NSCLC) AK112 + chemo combo demonstrated promising anti-tumor activities in 1L NSCLC regardless of PD-L1 expression PD-L1 negative (TPS：0%) PD-L1 positive (TPS ≥ 1%) ORR=46.2% DCR=100% ORR=80.0% DCR=100% PD-L1
Slide 33: AK112 – clinical efficacy data (Platinum-resistant ovarian cancer)
2 AK112 – clinical efficacy data (Platinum-resistant ovarian cancer) AK112 demonstrated Platinum-resistant superior ovarian cancer efficacy (9 patients resultsQ2W; in 20mg/kg in platinum-resistant ovarian 6 patients in 10mg/kg Q2W)cancer 20mg/kg: ORR = 33.3% (3/9), DCR = 88.9% (8/9) 10mg/kg: ORR = 1
Slide 34: AK112 – comprehensive development plan
2 AK112 (PD-1/VEGF) – comprehensive development plan Exciting clinical efficacy outlook Our focused, expedited development plan ✓Both mono and combo studies EGFRm-TKI/R demonstrated promising anti-tumor NSCLC activities in lung cancers and ovarian cancers Ovarian PD-L1(+) ✓We continue to explore mon
Slide 35: AK117 CD47 antibody
t Akesobio AK117 CD47 antibody
Slide 36: AK117 (CD47) – clinical development plan
3 AK117 (CD47) – clinical development plan AK117 is a potential best-in-class anti-CD47 mAB with elimiated hemagglutination effect Status Drug Comm. Pivotal/ NDA Target Mono/ Combo Indication Phase Ia Phase Ib/II Candidate Rights Phase III Submitted Mono Solid tumors/lymphoma +AK104 Adv. solid tumor
Slide 37: Response to AK117 (CD47)
3 Response to AK117 (CD47) Baseline Week 8 Peripheral T-cell lymphoma (PTCL) ➢ Female, 65 y/o ➢ Treated with AK117 10mg/kg QW (8 doses received) ➢ Prior anti-cancer therapy: CHOP(cyclophosphamide, doxorubicin, vincristine, prednisone) for 8 cycles ➢ SD (Target lesion:-47%) Baseline Week 8 Follicular
Slide 38: AK117 (CD47) – potential best-in-class CD47 with global rights
3 AK117 (CD47) – potential best-in-class CD47 with global rights AK117 is a potential best-in-class anti-CD47 mAb with eliminated hemagglutination effect 1 Superior safety feature • Superior safety in both pre-clinical and phase I clinical studies • Complete elimination of RBC hemagglutination • AK1
Slide 39: Penpulimab (AK105) PD-1 antibody
Penpulimab (AK105) PD-1 antibody 39
Slide 40: Penpulimab (PD-1) – significant progress achieved
4 Penpulimab (PD-1) – significant progress achieved Penpulimab demonstrates potential best-in-class safety profile, and clinically similar or superior to other approved anti-PD-1 agents, and ready for global development NDA approval and first batch of Penpulimab prescribed on Aug 23 NDA approval Fir
Slide 41: Penpulimab (PD-1) – clinical development plan
4 Penpulimab (PD-1) – clinical development plan Focusing on combo trials with Chemo or Anlotinib for large indications, combined with monotherapy trials for niche indications for rapid approval Status Drug Comm. Target Mono/Combo Indication Pivotal/ NDA/BLA Candidate Rights Phase Ia Phase Ib/II Phas
Slide 42: Non-oncology products
t Akesobio Non-oncology products
Slide 43: AK120 IL-4R antibody
t Akesobio AK120 IL-4R antibody
Slide 44: AK120 (Anti-IL-4R) – clinical development plan
5 AK120 (Anti-IL-4R) – clinical development plan Status Drug Comm. Target Mono/Combo Indication Pivotal/ NDA Candidate Rights Phase I Phase II Phase III Submitted Moderate-to-severe Mono atopic dermatitis Moderate-to-severe AK120 IL-4R Global Mono asthma Mono Eosinophilic esophagitis = In progress =
Slide 45: AK120 – clinical efficacy data summary (Phase Ib)
5 AK120 (Anti-IL-4R) – clinical efficacy data summary (Phase Ib) Good efficacy of AK120 in atopic dermatitis patients (EASI 75 and IGA 0/1 results) EASI 75 at Week 4 IGA 0/1 at Week 4 60% 50.0% 51.1% 50% 20% 19.5% 41.7% 40% 44.4% 39.1% 40.0% (4/9) 30% (4/10) 33.3% 31.3% (1/3) 29.0% 10% (10/32) 15.6%
Slide 46: AK120 – clinical efficacy data summary (Phase Ib)
5 AK120 (Anti-IL-4R) – clinical efficacy data summary (Phase Ib) Encouraging itch reduction effect in atopic dermatitis patients Average Weekly P-NRS Score Percentage Change Average Weekly P-NRS Score Percentage Change (Blinded Data) (Studies M4A and M4B) 1 20 20 10 10 Study week Study week 0 Mean P
Slide 47: AK120 – clinical pharmacodynamics data summary (Phase Ib)
5 AK120 (Anti-IL-4R) – clinical pharmacodynamics data summary (Phase Ib) Pharmacodynamics results in Atopic Dermatitis patients TARC/CCL17 Percentage Change from Baseline 80 80 AK120 Mean percentage change from baseline in TARC/CCL17 Dupilumab 1 Median Percent Change TARC from Baseline 60 60 40 40 2
Slide 48: Other clinical stage products
Other clinical stage products 48
Slide 49: Other clinical stage products
Other clinical stage products AK101 AK111 AK102 Anti-IL-12/IL-23 Anti-IL-17 Anti-PCSK9 Moderate-to-severe psoriasis • Completed Phase Ib trial for Hypercholesterolemia ✓ Phase III IND approved by moderate-to-severe ✓ Completed Phase II and NMPA, and Phase III initiated psoriasis. Phase II in Phase I
Slide 50: Other clinical stage products
Other clinical stage products AK119 AK109 Anti-CD73 Anti-VEGFR2 • AK119 on healthy volunteers • AK109 monotherapy on (Phase 1a) completed advanced solid tumors (Phase I) completed • AK119 + AK104 combo on advanced solid tumors on- • AK109 + AK104 or AK109 going +AK104 + chemo combo on >= 2L GC/GEJ (
Slide 51: Future Milestones and Catalysts
SECTION 3 Future Milestones and Catalysts
Slide 52: Future milestones and catalysts in 2H2021 and 2022
Future milestones and catalysts in 2H2021 and 2022 Registrational approvals Phase III/Pivotal trials ➢ Receive approvals for: ➢ AK104 (Cadonilimab) • Penpulimab (PD-1) in >=3L NPC ➢ AK112 (PD-1/VEGF) • Penpulimab (PD-1) in ➢ AK117 (CD47) combination with chemotherapy ➢ AK105 (Penpulimab) in 1L sq-NS
Slide 53: Key takeaways
Key takeaways Akeso is making solid and fast progress than expected. Both oncology and immunology programs have achieved significant milestones during the reporting period. Akeso is proud to have developed a comprehensive and complementary bi-specific product portfolio targeting a broad spectrum of
Slide 54: Financial Highlights
SECTION 4 Financial Highlights
Slide 55: Operating results
Operating results As of June 30, RMB in millions 2021 2020 1 Revenue • Revenue in 2021 represents milestone receipt from 1 Revenue 128.6 – our out-licensed product AK107 (MK1308) to Merck. Other income 65.9 41.0 2 R&D expenses (563.5) (240.7) … … 2 R&D expenses Administrative The increase of RMB322.
Slide 56: Balance sheet and cash flow statement
Balance sheet and cash flow statement Financial Position As of June 30, As of December 31, RMB in millions 2021 2020 Non-current assets 1,167.5 854.8 Current assets 3,632.8 3,001.3 1 - Cash at bank 3,163.9 2,684.5 1 Cash at bank Current liabilities 211.0 170.0 The increase in cash at bank was primar
Slide 57: Q&A
Q&A